Oxytocin Injection Recalled for Current Good Manufacturing Practice Violations
Fresenius Kabi Compounding is voluntarily recalling over 4,400 bags of Oxytocin 0.9% Sodium Chloride Injection due to current Good Manufacturing Practice violations. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall initiated voluntarily by the manufacturer for current Good Manufacturing Practice violations. No illnesses, injuries, or hospitalizations have been reported. The hazard is a manufacturing process deficiency rather than confirmed contamination, qualifying this as a precautionary recall.
Plain-English summary
Fresenius Kabi Compounding, LLC is recalling Oxytocin 0.9% Sodium Chloride Injection USP (30 units per 500 mL) due to current Good Manufacturing Practice (cGMP) violations. The recall affects 4,436 bags distributed to 125 direct accounts nationwide. Affected lot numbers are C274-000038801 (expiration 9-Oct-24), C274-000039045 (expiration 24-Oct-24), and C274-000039240 (expiration 31-Oct-24). The manufacturer voluntarily initiated the recall on September 25, 2024; the FDA classified it as Class II on October 21, 2024.
No illnesses or injuries have been reported in connection with this product. Healthcare providers and patients with this product should contact the manufacturer for guidance.
The recalled product
- Product
- Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 4,436
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # C274-000038801
- exp. date 9-Oct-24 C274-000039045
- exp. date 24-Oct-24 C274-000039240
- exp. date 31-Oct-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Fresenius Kabi Compounding, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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